Applied Clinical Informatics, Inhaltsverzeichnis Appl Clin Inform 2011; 02(01): 63-74DOI: 10.4338/ACI-2010-11-RA-0064 Research Article Schattauer GmbH Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases Authors Institutsangaben R.B. Myers 1 University of Texas School of Biomedical Informatics, Houston, TX 2 University of Texas M.D. Anderson Cancer Center, Houston, TX S.L. Jones 1 University of Texas School of Biomedical Informatics, Houston, TX 3 The Methodist Hospital, Houston, TX D.F. Sittig 1 University of Texas School of Biomedical Informatics, Houston, TX Artikel empfehlen Abstract Volltext als PDF herunterladen(opens in new window) Keywords KeywordsElectronic health records - information systems - mandatory reporting - medical errors - United States Food and Drug Administration Referenzen References 1 NPR Staff.. Anti-virus program update wreaks havoc with PCs: NPR [Internet]. 2010 Apr 21 [cited 2010 Apr 25];Available from: http://www.npr.org/templates/story/story.php?storyId=126168997&sc=17&f=1001 2 Dearne K. Medicare glitch affects records. The Australian [Internet]. 2010 Apr 20 [cited 2010 Apr 25]; Available from: http://www.theaustralian.com.au/australian-it/medicare-glitch-affects-records/story-e6frgakx-1225855706275 3 MAUDE –Manufacturer and User Facility Device Experience [Internet]. [cited 2010 Apr 15]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM 4 Koppel R, Kreda D. Health care information technology vendors’ "hold harm-less" clause: implications for patients and clinicians. JAMA 2009; 301 (12) 1276-1278. 5 Sittig DF, Classen DC. Safe electronic health record use requires a comprehensive monitoring and evaluation framework. JAMA 2010; 303 (05) 450-451. 6 Koppel R. Monitoring and evaluating the use of electronic health records. JAMA 2010; 303 (Suppl. 19) 1918 author reply 1918-1919. 7 Goodman KW, Berner ES, Dente MA, Kaplan B, Koppel R, Rucker D. et al. Challenges in ethics, safety, best practices, and oversight regarding HIT ven-dors, their customers, and patients: a report of an AMIA special task force. J Am Med Inform Assoc 2011; 18 (01) 77-81. doi:10.1136/jamia.2010.008946. 8 Norden L. Voting system failures: a database solution [Internet]. New York N Y.: Brennan Center for Justice; 2010 [cited 2010 Sep 20]. Available from: http://www.brennancenter.org/content/resource/voting_system_failures_a_database_solution 9 CFR –Code of Federal Regulations Title 21 [Internet]. [cited 2011 Jan 8]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1&subpartNode=21:8.0.1.1.3.5 10 FDA policy for the regulation of computer products. 11/13/89 (Draft) [Internet]. [cited 2011 Jan 28]; Available from: http://www.janosko.com/documents/FDA%20Policy%20Computer%20Products/FDAPolicyComputers1989.htm 11 MDR Database Search [Internet]. [cited 2010 Apr 20]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm?searchoptions=1 12 Medsun Reports [Internet]. [cited 2010 Apr 15]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/searchReport.cfm 13 MedSun: Medical Product Safety Network [Internet]. [cited 2010 Apr 15]; Available from: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm 14 Campbell EM, Sittig DF, Guappone KP, Dykstra RH, Ash JS. Overdependence on technology: an unintended adverse consequence of computerized pro-vider order entry. AMIA Annu Symp Proc 2007: 94-98. 15 Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc 2006; 13 (05) 547-556. doi:10.1197/jamia. M2042. 16 Sittig DF, Singh H. Eight rights of safe electronic health record use. JAMA 2009; 302 (10) 1111-1113. 17 DeVore SD, Figlioli K. Lessons premier hospitals learned about implementing electronic health records. Health Aff (Millwood) 2010; 29 (04) 664-667. doi:10.1377/hlthaff.2010.0250. 18 Han YY, Carcillo JA, Venkataraman ST, Clark RSB, Watson RS, Nguyen TC. et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics 2005; 116 (06) 1506-1512. doi:10.1542/peds.2005-1287. 19 Del Beccaro MA, Jeffries HE, Eisenberg MA, Harry ED. Computerized pro-vider order entry implementation: no association with increased mortality rates in an intensive care unit. Pediatrics 2006; 118 (01) 290-295. doi:10.1542/peds.2006-0367. 20 Linder JA, Haas JS, Iyer A, Labuzetta MA, Ibara M, Celeste M. et al. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf 2010; 19 (12) 1211-1215. doi:10.1002/pds.2027. 21 Dal Pan GJ. Commentary on "Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting" by Linder et al. Pharma-coepidemiol Drug Saf 2010; 19 (12) 1216-1217. doi:10.1002/pds.2050. 22 CCHIT [Internet]. [cited 2010 Apr 15]; Available from: http://www.cchit.org 23 Ambulatory EMR –Segment Profile –KLAS Helps Healthcare Providers by Measuring Vendor Performance [Internet]. [cited 2010 Apr 15]; Available from: http://www.klasresearch.com/Research/Segments/Default.aspx?id=3&evProductID=33609&ReturnURL=%2fResearch%2fSegments%2fDefault.aspx%3fid%3d3%26evProductID%3d33609 24 Jha AK, DesRoches CM, Campbell EG, Donelan K, Rao SR, Ferris TG. et al. Use of electronic health records in U. S. hospitals. N Engl J Med 2009; 360 (16) 1628-1638. doi:10.1056/NEJMsa0900592. 25 H.R.1 [111th]: American Recovery and Reinvestment Act of 2009 (Gov-Track.us) [Internet]. [cited 2011 Jan 14]; Available from: http://www.govtrack.us/congress/bill.xpd?bill=h111-1 26 Hsiao C, Beatty P, Hing E, Woodwell D, Rechtsteiner E, Sisk J. Products –Health E Stats –EMR and EHR Use by Office-based Physicians [Internet]. [cited 2011 Jan 14]; Available from: http://www.cdc.gov/nchs/data/hestat/emr_ehr/emr_ehr.htm 27 Shuren J. Testimony of Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health [Internet]. 2010 Available from: http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10741_910717_0_0_18/3Shuren_Testimony/022510.pdf 28 *ASTER Study [Internet]. [cited 2010 Aug 10]; Available from: http://www.asterstudy.com 29 Issue 42: Safely implementing health information and converging technologies | Joint Commission [Internet]. [cited 2010 Aug 7]; Available from: http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm 30 Federal Aviation Administration. Aeronautical information manual –official guide to basic flight information and ATC procedures [Internet]. 2010 Feb 11; Available from: http://www.faa.gov/air_traffic/publications/atpubs/aim/ 31 Miller RA, Gardner RM. Recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Science Libraries, American Health Information Management Association, American Nurses Association. J Am Med Inform Assoc 1997; 4 (06) 442-457. 32 PSO Privacy Protection Center –Device or Medical/Surgical Supply, including HIT Device (Beta) [Internet]. [cited 2011 Jan 18]; Available from: https://www.psoppc.org/web/patientsafety/device-ormedical/surgical-supply-including-hit-device-beta 33 Patient Safety and Health Information Technology - Institute of Medicine [Internet]. [cited 2011 Jan 18]; Available from: http://www.iom.edu/Activities/Quality/PatientSafetyHIT.aspx
